Etidron

 
Composition:-
Each tablet contains:
Etidronate disodium                  200 mg

Properties:
Etidron is a preparation containing etidronate disodium that inhibits the formation, growth and dissolution of hydroxyapatite crystals and their amorphous precursors by chemisorption to calcium phosphate surfaces.

Indications & usage:-
Etidron is indicated for:
-    Treatment of symptomatic Paget's disease of bone (idiopathic, progressive disease characterized by abnormal and accelerated bone metabolism in one or more bones).  
-    Prevention and treatment of heterotopic ossification following total hip replacement or due to spinal cord injury.
-    Treatment of osteoporosis, prevention and treatment of bone loss in postmenopausal women, prevention and treatment of corticosteroid-induced osteoporosis.
-    Treatment of hypercalcaemia of malignancy.

Contraindications:-
Etidron is contraindicated in:
-    Patients with known hypersensitivity to etidronate disodium.
-    Patients with clinically overt osteomalacia.

Side effects:

Some of the following side effects may occur in some cases:-
- Diarrhea, nausea, arthropathies, esophagitis, glossitis and hypersensitivity reactions.
- In Paget's patients, there may be increased or recurrent bone pain at the pagetic site, when therapy continues, pain resolves in some patients but persists in others.

Drug interactions:
There have been isolated reports of patients experiencing increases in their prothrombin times when Etidron was added to warfarin therapy.
Patients on warfarin should have their prothrombin time monitored.

Warnings & Precautions:-
-    In Paget's patients, the response to therapy may be of slow onset and continue for months after Etidron therapy is discontinued. A 90-day free interval should be provided between courses of therapy.
-    Patients should maintain an adequate nutritional status, particularly an adequate intake of calcium and vitamin D.
-    Hyperphosphatemia may occur at doses of 10 to 20 mg/kg/day.
Serum phosphate levels return to normal 2 to 4 weeks posttherapy.
-    Etidron dosage should be reduced when reduction in glomerular filtration rates are present.
-    In Paget's patients, treatment regimens exceeding the recommended daily maximum dose of 20 mg/kg or continuous administration of medication for periods greater than 6 months may be associated with osteomalacia and an increased risk of fracture.
-    In patients with fractures, especially of long bones, it is advisable to delay or interrupt treatment with Etidron until callus is evident.      

Pregnancy:
Etidron should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Lactation:

Caution should be exercised when Etidron is administered to a nursing woman.

Overdosage:
In case of overdosage, signs and symptoms of hypocalcemia may occur.
Prolonged continuous treatment (chronic overdosage) has been reported to cause nephrotic syndrome and fracture.

Treatment:
-    Gastric lavage may remove unabsorbed drug.
-    Standard procedures for treating hypocalcemia including the administration of calcium intravenously.

Dosage and Administration:-
Etidron is taken as a single dose, or in divided doses.
To maximize absorption, patients should avoid taking the following items within two hours of dosing:
- Food, especially food high in calcium such as milk or milk products.
- Vitamins with mineral supplements or antacids which are high in calcium, iron, magnesium or aluminium metals.

Paget's disease:
5 –10 mg/kg/day for a period not to exceed 6 months, or 11-20 mg/kg/day, not to exceed 3 months.

Retreatment should be initiated only after a drug free period of at least 3 months and after evidence of active disease process, it should not be continued for more than 6 months.
Doses above 10 mg/kg/day should be reserved for when lower doses are ineffective or there is an overriding need to suppress rapid bone turn over.
Doses in excess of 20 mg/kg/day are not recommended.

Heterotopic ossification:
Total Hip Replacement Patients: 20 mg/kg/day for 1 month before and 3 months after surgery.
Spinal Cord Injured patients: 20 mg/kg/day for 2 weeks followed by 10 mg/kg/day for 10 weeks.

Osteoporosis:
400 mg daily for 14 days followed by the equivalent of 500 mg of elemental calcium by mouth for 76 days.

Hypercalcaemia of malignancy:
Maintenance therapy: 20 mg/kg daily for 30 days.
Treatment may be extended to a maximum of 90 days.

Therapeutic category: Bone metabolism regulator, antipagetic agent, antihypercalcemic agent.

Legal category: POM.

Package:
Box containing 20 tablets.

Storage:
Store in a dry place, at a temperature below 30º C.

THIS IS A MEDICAMENT
Medicament is a product, which affects your health and its consumption contrary to instructions is dangerous for you. Follow strictly the doctor’s prescription, the method of use and the instructions of the pharmacist who sold the medicament.
- The doctor and the pharmacist are the experts in medicines, their benefits and risks.
- Do not by yourself interrupt the period of treatment prescribed.
- Do not repeat the same prescription without consulting your doctor.
- Keep all medicaments out of reach of children.

Council of Arab Health Ministers, Union of Arab Pharmacists.